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LAU-7b for COVID-19 (RESOLUTION Trial)
RESOLUTION Trial Summary
This trial is testing a new drug to see if it can help people with COVID-19 who are hospitalized and at risk for complications.
RESOLUTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRESOLUTION Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RESOLUTION Trial Design
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Who is running the clinical trial?
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- You have very advanced cancer.You have or have had severe liver problems.You have severe kidney disease or need dialysis treatment.You have specific health conditions or risk factors including diabetes, heart or lung disease, history of smoking, obesity, positive COVID-19 test, or being in a hospital for COVID-19 treatment. You must be able to understand and consent to the study, and be able to take the study drug by swallowing capsules.Your kidneys are not working well, and your doctor has measured your kidney function to be less than 50 ml/min.You have an inherited eye condition called retinitis pigmentosa.You are expected to be moved to the intensive care unit (ICU) or pass away within the next 24 hours.You have a severe allergy to retinoids or to the ingredients in the oral capsule used in the study.You have a fever and a low number of a type of white blood cells called neutrophils.You must have symptoms of COVID-19 when you get screened or since you were admitted to the hospital.Your liver tests show high levels of bilirubin, ALT, or AST.
- Group 1: LAU-7b
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there previous examples of LAU-7b being tested in a clinical setting?
"LAU-7b was first investigated in 2020 by the Wake Forest University Health Science team. As of now, 187 trials have been completed while 2 are still recruiting participants. The majority of these studies are being conducted in Salt Lake City, Utah."
Does this research have a global reach?
"University of Utah Health, NorthShore University Health System - Glenbrook Hospital, and University Medical Center are a few of the hospitals participating in this trial. There are also 24 other sites located throughout the country."
Why did researchers design this clinical study in this way?
"The purpose of this clinical trial is to compare the outcomes of patients receiving a new medication to those receiving a placebo. The primary outcome measure is the proportion of patients requiring mechanical ventilation or who have died by Day 60. Secondary outcome measures include the rate of disease-related transfer to mechanical ventilation, time to mechanical ventilation, and mean change in health status as measured by the World Health Organization 7-point ordinal scale."
Is this research unprecedented in the medical field?
"As of now, there are 2 ongoing clinical trials for LAU-7b in 28 different cities spread across 2 countries. The first trial was conducted in 2020 and was completed in Phase 2 & 3. It was sponsored by Laurent Pharmaceuticals Inc. and had 508 participants. In the years since 2020, an additional 187 trials have been carried out."
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